Systemic toxicity is the potential adverse effect of medical devices caused by leachable substances of the product or its materials during use. This is because these leachable substances may produce general systemic toxic effects on tissues or organs that are not in direct contact with the product through absorption, distribution and metabolism. Systemic toxicity includes acute toxicity, subacute toxicity, subchronic toxicity and chronic toxicity tests. Among them, chronic toxicity tests are adverse effects that occur in the test individual during most of the life span after repeated or continuous contact with the test sample. Chronic systemic toxicity studies usually last 6 to 12 months.
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